Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 ONWARD's ARC-EX Granted Breakthrough Status for Several Indications - Orthopedic Design & Technology

What are you searching for?

Sign in
OEM News

ONWARD’s ARC-EX Granted Breakthrough Status for Several Indications

Specifically, bladder control, alleviation of spasticity, and blood pressure regulation after spinal cord injury.

Author Image

By: Sam Brusco

Associate Editor

ONWARD Medical, a company creating therapies to restore movement, independence, and health in people with spinal cord injury (SCI), has been granted U.S. Food and Drug Administration (FDA) breakthrough status for use of its ARC-EX platform for bladder control, spasticity alleviation, and blood pressure regulation in people with SCI.
 
The company has now been awarded eight total Breakthrough Device Designations.
 
The ARC-EX external, non-invasive platform is a stimulator and wireless programmer. The company’s first pivotal study, Up-LIFT, reported positive top-line data in 2022. The study evaluated ARC-EX therapy to improve upper extremity strength and function.
 
ONWARD is currently preparing for regulatory submissions in the U.S. and Europe, aiming to achieve approval for commercialization in late 2023.
 
“Bladder control, spasticity, and blood pressure dysregulation are three of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” Dave Marver, CEO of ONWARD told the press. “We are proud of our eight total Breakthrough Device Designations from the FDA, which validate the significant unmet needs of the SCI community and the pioneering nature of our work.”

Add us as a preferred source on Google

Get the latest Orthopedic Design & Technology news, insights and analysis in your Google Search and AI experiences.

Add Orthopedic Design & Technology as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Orthopedic Design & Technology Newsletters

Topics